Here are the latest stories being discussed in biopharma today:
Lilly Budgets Additional $5.3B for Tirzepatide API Factory in Indiana
Eli Lilly is significantly increasing its investment in Indiana by earmarking an additional $5.3 billion for an active pharmaceutical ingredient (API) production facility. This enhancement brings the total project budget to $9 billion, up from the initial $3.7 billion commitment. The expanded funding will also create 200 new jobs, boosting the total workforce at the facility to 900. CEO David Ricks highlighted that this marks the largest manufacturing investment in the company’s history and potentially the largest in synthetic medicine API manufacturing in the United States.
Startup Hims Plans for Custom Weight Loss Shots
Digital health company Hims & Hers is stepping into the GLP-1 weight loss market with a compounded version of semaglutide, the active ingredient in Novo Nordisk’s popular drugs Ozempic and Wegovy. Despite the current supply shortages, Hims intends to offer these custom weight loss shots long-term. Their version, costing $199 a month, provides a more affordable alternative to Wegovy’s $1,350 list price. Hims’ entry into this market has already boosted its stock by 30%.
FDA Denies Ipsen’s Petition for Somatuline
The FDA has denied Ipsen’s citizen petition aimed at delaying generic competition for Somatuline Depot. Ipsen had requested additional requirements for the approval process of generics for this tumor growth inhibitor, which also treats the rare disease acromegaly. The drug, first approved in 2007, generated $1.1 billion in 2023. However, revenues have declined with the entrance of generic versions.
Public Citizen Sues FDA Over SSRI Sexual Side Effects Labeling
Consumer advocacy group Public Citizen has filed a lawsuit against the FDA, demanding the agency require drugmakers to warn about potential long-term sexual side effects of SSRIs and SNRIs. The current labeling mandates warnings about sexual dysfunction during use but does not address persistent side effects after discontinuation of the drugs. The lawsuit follows an earlier citizen petition from doctors calling for this additional information to be included.
Novo Reports Cardio, Death Risk Reduction for Semaglutide in Kidney Disease
Novo Nordisk has shared promising results from a Phase 3 study showing that semaglutide significantly reduces the risk of major cardiovascular events and death in patients with type 2 diabetes and chronic kidney disease. These results were presented at the European Renal Association’s conference and published in the New England Journal of Medicine. The study, which previously showed a 24% reduction in kidney disease progression, was halted early due to its efficacy.
Pfizer Shares Data that Prompted Phase 3 Lung Cancer Trial
Pfizer has released updated data on sigvotatug vedotin, an antibody-drug conjugate acquired through its $43 billion deal with Seagen, which convinced the company to move directly from Phase 1 to Phase 3 trials. The data revealed that approximately 20% of lung cancer patients experienced a 30% tumor reduction, with a 32.5% response rate among patients with non-squamous, non-small cell lung cancer.